Overall MACE occurred in 108 patients of 1648 (6.6%) on Ozempic® (0.5 mg and 1 mg) and 146 patients of 1649 (8.9%) on placebo (HR, 0.74 [95% CI, 0.58-0.95] P<0.001 for noninferiority, P=0.02 for superiority, not prespecified); nonfatal stroke occurred in 27 patients (1.6%) on Ozempic® and 44 patients (2.7%) on placebo; nonfatal Ml occurred in 47 patients (2.9%) on Ozempic® and 64 patients (3.9%) on placebo; CV death occurred in 44 patients (2.7%) on Ozempic® and 46 patients (2.8%) on placebo.1
iStandards of care included, but were not limited to, oral antidiabetic treatments, insulin, antihypertensives, diuretics, lipid-lowering therapies, and antithrombotic medications.
jHazard ratio vs placebo (95% CI). Median study observation time of 2.1 years. Cox proportional-hazards models with treatment as factor and stratified by evidence of cardiovascular disease, insulin treatment, and renal impairment. P values other than for the primary hypothesis (noninferiority) are unadjusted for multiplicity and test null hypotheses of no difference.1,7,8
kP value is not adjusted for multiplicity and tests null hypotheses of no difference (post hoc).
lThe primary endpoint in the SUSTAIN 6 CVOT was time to first occurrence of a 3-part composite MACE that included CV death, nonfatal MI, or nonfatal stroke.
ARR=absolute risk reduction; CI=confidence interval; CVOT=cardiovascular outcomes trial; RRR=relative risk reduction; SOC=standard of care; CV=cardiovascular; CVD=cardiovascular disease; HR=hazard ratio; MACE=major adverse cardiovascular event; NS=nonsignificant.